OBJECTIVE: To determine the therapeutic effect and safety of transcatheter closure of ventricular septal defects (VSD) in 50 patients. METHODS: Fifty patients were diagnosed by transthoracic echocardiography. To perform the operation, transthoracic echocardiography and X ray were used continuously to monitor the procedure. Transthoracic echocardiography and ECG were performed at 1, 3, and 6 months after the operation to evaluate the therapeutic effect. RESULTS: The VSD diameter ranged from 1.8 to 13.4 (5.54 +/- 2. 75) mm. The successful rate of the operation was 96.0%, and the complication rate of the operation was 16.7%. A 3 month follow-up was completed in 20 patients, and the median left ventricle end-diastolic dimension significantly decreased from (40.20 +/- 8.80) mm to (32.90 +/- 8.36) mm (P < 0.001). CONCLUSION Transcatheter closure of ventricular septal defects is a good method with a high success rate of placement, fewer complications, and a good occlusion effect.
Adolescent ; Adult ; Balloon Occlusion ; adverse effects ; instrumentation ; methods ; Cardiac Catheterization ; methods ; Child ; Child, Preschool ; Echocardiography ; Female ; Heart Septal Defects, Ventricular ; diagnostic imaging ; therapy ; Humans ; Male ; Prostheses and Implants ; Treatment Outcome

Background: Extensive studies have confirmed the efficacy of taxanes in combination with anthracycline-basedchemotherapy on breast cancer. However, few studies have assessed the efficacy of weekly taxane–anthracyclineregimens on locally advanced breast cancer. This study was to compare the efficacy and safety of a weekly taxane–anthracycline regimen with those of tri-weekly anthracycline-based regimen in patients with locally advanced breastcancer.Methods: Patients with locally advanced breast cancer were randomized to receive 4–6 cycles of neoadjuvant chemotherapywith tri-weekly 5-fluorouracil–epirubicin–cyclophosphamide (FEC) regimen or weekly paclitaxel–epirubicin(PE) regimen. The primary endpoint was the pathologic complete response (pCR) rate. Other endpoints included theclinical tumor response, breast-conserving surgery rate, and adverse events.Results: Between March 2010 and September 2013, 293 patients were randomized to the FEC (n = 151) and PE(n = 142) arms. The overall clinical response rate was significantly higher in the PE arm than in the FEC arm (76.06% vs.59.95%, P = 0.001). Consistently, the post-chemotherapy pathologic T and N stages were significantly lower in the PEarm than in the FEC arm (P < 0.001). However, the pCR rate was similar in the two arms (10.61% vs. 12.31%, P = 0.665).Overall, 36 (27.27%) patients in the FEC arm and 6 (35.28%) in the PE arm were qualified for breast-conserving surgery.Most adverse events were comparable in both arms, with more severe neutropenia in the PE arm than in the FEC arm(11.97% vs. 5.96%, P = 0.031).Conclusions: In patients with locally advanced breast cancer, weekly PE was not superior to FEC in terms of pCR.However, weekly PE has a higher response rate and superior down-staging effects. On this account, the PE regimenmay be considered an alternative option for locally advanced breast cancer. Long-term follow-up data are needed toconfirm the efficacy of this regimen on locally advanced breast cancer.

Objective To observe the clinical efficacy and safety of edaravone and dexborneol concentrated solution for injection in the treatment of patients with ischemic stroke.Methods Patients with acute ischemic stroke were divided into two groups,the control group was given conventional treatment,the treatment group was given edaravone and dexborneol concentrated solution for injection 15 mL on the basis of conventional treatment.The clinical efficacy of the two groups was compared.The National Institutes of Health stroke scale(NHISS)score was used to evaluate the neurological function of the patients,the modified RanKin scale(mRS)was used to evaluate the ability of daily living of the patients,and the adverse drug reactions during the treatment was observed.Results There were 63 cases in the control group and 75 cases in the treatment group.After treatment,the total effective rates of the treatment group and the control group were 85.33％(64 cases/75 cases)and 65.07％(41 cases/63 cases),and the difference was statistically significant(P＜0.05).After treatment,the differences of NHISS score before and after treatment in the treatment group and the control group were(2.11±1.01)and(0.99±0.68)points;the differences of mRS score were(0.96±0.57)and(0.63±0.41)points,and the differences were statistically significant(P＜0.01,P＜0.05).The adverse drug reactions in the two groups were nausea and vomiting,abnormal liver and kidney function.The total incidences of adverse drug reactions in the treatment group and control group were 2.67％and 6.35％,and the difference was not statistically significant(P＞0.05).Conclusion Edaravone and dexborneol concentrated solution for injection can improve the therapeutic effect of acute ischemic stroke without increasing the incidence of adverse drug reactions.

OBJECTIVE: To access the possibility, methods and efficacy of simultaneous transcatheter therapy for ventricular septal defect ( VSD ) combined with atrial septal defect (ASD). METHODS: In 68 patients with VSD, four patients ranging from 3 to 24 years old were combined with ASD. The diameters of perimembranous VSD were 2 approximately 10.5 mm, and the diameters of secundum ASD were 4.6 approximately 7 mm under the echocardiography before the operation. Another 4 patients with VSD occluded by left ventriculography: 3 patients were occluded by VSD occluder first, and then occluded by ASD occuder. The other was only occluded by VSD occluder. RESULTS: All VSD was treated successfully at one time in 4 patients. The diameters of VSD occluder were 4, 8, 10, and 16 mm. ASD was occluded successfully at one time in 3 patients. The diameters of ASD occluder were 8, 10, and 10 mm. The successful rate of the operation was 100%. No complication occurred in the operation and follow-up. CONCLUSION Simultaneous transcatheter closure for VSD combined with ASD is a safe, feasible and effective therapy.
Abnormalities, Multiple ; therapy ; Adolescent ; Adult ; Balloon Occlusion ; instrumentation ; methods ; Cardiac Catheterization ; methods ; Child ; Child, Preschool ; Echocardiography ; Female ; Heart Septal Defects, Atrial ; therapy ; Heart Septal Defects, Ventricular ; therapy ; Humans ; Male ; Treatment Outcome

OBJECTIVE: To evaluate the short and mid-term changes of the cardiac morphology after percutaneous transcatheter closure of ventricular septal defects (VSD) with transthoracic echocardiography (TTE). METHODS: The left ventricular end-diastolic diameter (LVEDD), left ventricular end-diastolic volume (LVEDV), left atrial diameter (LAd), and right ventricular diameter (RVd) in 30 VSD patients were measured before the VSD closure,and on the 3rd day, 3rd month, and 6th month after the VSD closure by TTE. RESULTS: LVEDD and LVEDV significantly decreased on the 3rd day after the VSD closure compared with pre-VSD closure. LVEDD and LVEDV continuously decreased on the 3rd month and 6th month after the VSD closure. LAd was smaller on the 3rd month and 6th month after the VSD closure, but there was not significant difference between the 3rd and 6th month. RVd increased on the 3rd day after the VSD closure, while no significant difference was found among the 3rd month and 6th month before and after VSD closure. CONCLUSION Percutaneous transcatheter VSD closure may effectively improve the cardiac remodeling in VSD patients in the short and mid-term follow-up.
Adolescent ; Adult ; Cardiac Catheterization ; methods ; Child ; Child, Preschool ; Echocardiography ; Female ; Follow-Up Studies ; Heart Septal Defects, Ventricular ; diagnostic imaging ; therapy ; Humans ; Male ; Prosthesis Implantation ; methods ; Time Factors ; Ventricular Remodeling

OBJECTIVE: To explore the value of transthoracic echocardiography (TTE) in transcatheter closure of atrial septal aneurysm (ASA) combined with secoundum-type atrial septal defect (ASD). METHODS: Fourteen patients (3 males and 11 females) who had ASA combined with secoundum-type ASD were diagnosed by TTE or transesophageal echocardiography. The ASA projected to the right atrium in all patients. The width of basilar part was 13 approximately 24 (18.5+/-3.9) mm, and the vertical extent was 7 approximately 11(9.7+/-1.8) mm. Ten patients combined with single hole ASD and 4 patients with multiple hole ASD. Blood shifting from the left atrium to the right atrium was displayed in color Doppler in all patients. All patients were treated by transcatheter closure under the guiding of X fluoroscopy and TTE, and examined with TTE during the follow-up. RESULTS: Transcatheter closure was successfully performed by 14 occluders in all patients. No residual shunt was detected immediately by TTE after the procedure in all patients. During the 6 approximately 12 month follow-up, no residual shunt or occluder shifting was found, the dimensions of the heart became normal in 11 patients (79%) and were significantly decreased in 4. CONCLUSION Transcatheter closure is feasible in patients with ASA combined with secoundum-type ASD, and extra attention must be paid to the specialty. TTE is very important in case selection before transcatheter closure, and it may be used to monitor and guide the procedure during transcatheter closure.
Adult ; Atrial Septum ; Balloon Occlusion ; methods ; Cardiac Catheterization ; Echocardiography ; Female ; Heart Aneurysm ; complications ; therapy ; Heart Septal Defects, Atrial ; complications ; therapy ; Humans ; Male ; Middle Aged ; Ultrasonography, Interventional ; Young Adult

OBJECTIVE: To assess the effects of intracoronary diltiazem on no-reflow phenomenon of infarct-related artery (IRA) after emergent percutaneous transluminal coronary angioplasty or/and intracoronary stenting (PTCA/Stenting) in the patients with acute myocardial infarction (AMI). METHODS: We studied 34 AMI patients with no-reflow phenomenon of IRA after emergent PTCA/Stenting between January 1999 and August 2005. Urokinase-treated group (n=16) was given intracoronary urokinase 30,0000 - 50,0000 units within 15 - 30 minutes between January 1999 and April 2002 while diltiazem-treated group (n=18) was given intracoronary diltiazem 0.5 - 2 mg within 10 - 30 minutes between May 2002 and August 2005. Fifteen minutes later, coronary arteriography (CAG) was performed and the thrombolysis in myocardial infarction (TIMI) flow grade was measured. RESULTS: No apparent change of TIMI flow grade was found between pre-administration and post-administration of intracoronary urokinase, but TIMI flow grade was significantly improved after intracoronary diltiazem (P<0.01). TIMI flow grade of diltiazem-treated group was significantly higher than that of urokinase-treated group after the administration (P<0.05). The percentage of the patients who reached TIMI flow grade 3 after the intracoronary administration was higher in the diltiazem-treated group than that in the urokinase-treated group (P<0.01). CONCLUSION The intracoronary administration of diltiazem 0.5~2mg can effectively improve the no-reflow phenomenon after emergent PTCA/Stenting in patients with AMI.
Adult ; Aged ; Angioplasty, Balloon, Coronary ; Diltiazem ; administration & dosage ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Myocardial Infarction ; therapy ; No-Reflow Phenomenon ; drug therapy ; Stents ; Treatment Outcome

Objective To establish a high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS)for the simultaneous determination of gefitinib,erlotinib,nillotinib and imatinib plasma concentrations and analyze the results.Methods The plasma samples were treated with acetonitrile precipitation and separated by Diamonsil C18 column(150 mm ×4.6 mm,3.5 μm)with mobile phase of 0.1％formic acid water(A)-0.1％formic acid acetonitrile(B).The flow rate of gradient elution was 0.7 mL·min-1,and the column temperature was 40 ℃ and the injection volume was 3 μL.Using arotinib as the internal standard,the scanning was carried out by using electrospray ionization source in positive ionization mode with multi-reaction monitoring.The specificity,standard curve,lower limit of quantitation,precision,accuracy,recovery rate,matrix effect and stability of the method were investigated.The concentrations of imatinib and erlotinib in 20 patients with chronic myelogenous leukemia(CML)and gefitinib and erlotinib in 3 patients with non-small cell lung cancer were measured.Results The standard curves of the four drugs were as follows,gefitinib:y=2.536 × 10-3x+9.362 × 10-3(linear range 20-2 000 ng·mL-1,R2=0.996 6);erlotinib:y=3.575× 10-3x+7.406 × 10-3(linear range 50-5 000 ng·mL-1,R2=0.994 9);nilotinib:y=1.945 x 10-3x+0.015 643(linear range 50-5 000 ng·mL-1,R2=0.990 6);imatinib:y=4.56 x 10-3x+0.010 451(linear range 100～104 ng·mL-1,R2=0.9963).RSD of intra-day and inter-day were less than 10％,and the accuracy ranged from 90％to 110％,and the recovery rates were 91.35％to 98.93％(RSD＜10％);the matrix effect ranged from 91.64％to 107.50％(RSD＜10％).Determination of 23 patients showed that the blood concentration of nilotinib ranged from 623.76 to 2 934.13 ng·mL-1,and the blood concentration of imatinib ranged from 757.77 to 2 637.71 ng·mL-1,and the blood concentration of gefitinib ranged from 214.76 to 387.40 ng·mL-1.The serum concentration of erlotinib was 569.57 ng·mL-1.Conclusion The method of this research is simple,fast,sensitive and dedicated,which can be monitored by the concentration of clinical blood.

Objective To establish a liquid chromatography tandem mass spectrometry(LC-MS/MS)method for the determination of polymyxin B and tigecycline in rat plasma and to study the pharmacokinetic profile in rats.Methods Rat plasma was treated with 3％trichloroacetic acid-methanol solution(50∶50)for protein precipitation on a Symmetry C18(150.0 mm × 4.6 mm,3.5 μm)column,with mobile phase:0.1％formic acid in water-0.1％formic acid in acetonitrile at a flow rate of 0.6 mL·min-1,the column temperature was 40 ℃,and the ionization source was electrospray ionization,positive ion detection mode:multiple reaction detection.The method was investigated for its specificity,standard curve and lower limit of quantification,precision and recovery,stability and reproducibility.Results The linear range of tigecycline was 25-2 500 ng·mL-1,the lower limit of quantification was 25 ng·mL-1,and the extraction recovery was 95.89％-107.90％;the linear range of polymyxin B,was 82-8 200 ng·mL-1,the lower limit of quantification was 80 ng·mL-1,and the extraction recovery was 93.84％-97.70％;the linear range of polymyxin B2 was 9-900 ng·mL-1,the lower limit of quantification was 9 ng·mL-1,the extraction recovery was 96.41％-104.80％;the intra-day and inter-day relative standard deviations of each substance were 96.41％-104.80％.The linear range was 9-900 ng·mL-1,the lower limit of quantification was 9 ng·mL-1,and the extraction recoveries were 96.41％-104.80％.The intra-day and inter-day relative standard deviations of each substance were less than 10％,and the stability and reproducibility were good.Conclusion This method is simple,sensitive,and has a short analytical time,and is suitable for the determination of the blood concentration of polymyxin B and tigecycline in rat plasma as well as for pharmacokinetic studies.

OBJECTIVETo study the safety and immunogenicity of the Bilive combined hepatitis A and B vaccine produced by Sinovac Biotech Co., Ltd.

METHODSSamples were selected from first year students of a senior high school (adults group) and first to fifth grade 1-5 students of 3 primary schools (children group). Those who were susceptible to both hepatitis A virus (HAV) and hepatitis B virus (HBV), HAV only or HBV only were assigned to group AB, A and B respectively and were vaccinated with three doses (0, 1 and 6 month schedule) of Bilive combined hepatitis A and B vaccine, inactivated hepatitis A vaccine and recombined hepatitis B vaccine respectively. The dosage for adult group was 500 U hepatitis A antigen and/or 10 micro g hepatitis B surface antigen and the dosage for children group was half the dosage of adult group. The potential adverse effects were observed within 72 hours after vaccination. Serum samples were collected for testing anti-HAV and anti-HBs at month 2 and 7 after the initial dose.

RESULTSThe rates of local adverse effects were 0.58% and 2.56% in children AB group and adults AB group and the general adverse effects rates were 9.88% and 5.45% respectively. Both local and general adverse effect rates were not significantly different to the control group. The sero-conversion rate of anti-HAV in children and adults AB group reached 100%, one month after 3 doses. The geometric mean titer (GMTs) reached 33,910 mIU/ml and 23,435 mIU/ml respectively, significant higher than that in control group (group A). The sero-conversion rates of anti-HBs were 97.30% and 96.63%, and GMTs were 103 mIU/ml and 102 mIU/ml in children and adults AB group respectively. No significant difference on sero-conversion and GMT was observed when compared with control group.

CONCLUSIONThe Bilive combined hepatitis A and B vaccine had good safety profile, and the immunogenicity both on anti-HAV and anti-HBs was similar to that of separated components.

Adolescent ; Adult ; Child ; Female ; Hepatitis A ; prevention & control ; Hepatitis A Antibodies ; blood ; Hepatitis A Vaccines ; administration & dosage ; adverse effects ; immunology ; Hepatitis Antibodies ; blood ; Hepatitis B ; prevention & control ; Hepatitis B Antibodies ; blood ; Hepatitis B Vaccines ; administration & dosage ; adverse effects ; immunology ; Humans ; Male ; Safety ; Vaccines, Combined ; administration & dosage ; adverse effects ; immunology ; Vaccines, Synthetic ; administration & dosage ; adverse effects ; immunology